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Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228462
First Posted: September 29, 2005
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
September 27, 2005
September 29, 2005
January 4, 2013
March 2005
Not Provided
The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
  • The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating
  • relapse prevention in long-term use in patients with schizophrenia as measured by the time to
  • first psychiatric relapse up to one year
Complete list of historical versions of study NCT00228462 on ClinicalTrials.gov Archive Site
To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
  • To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse
  • in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
Not Provided
Not Provided
 
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)
This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Drug: Seroquel (quetiapine)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
April 2006
Not Provided

Inclusion Criteria:

  • Stable schizophrenic patients who have provided written informed consent
  • Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).

Exclusion Criteria:

  • Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
  • Expected non-compliance to treatment
  • Known diabetes mellitus,
  • Contraindications,
  • Intolerance or non-responsiveness to Seroquel or other safety issues.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Poland
 
 
NCT00228462
D1444C00004
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP